Regulatory Affairs Specialist

Profile

Regulatory Affairs Specialist
Duties: Identify regulatory requirements for new products or product enhancements early in the product development cycle. Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims. Review product revision requests to assure compliance with regulatory requirements. Work on product teams to develop regulatory strategy based on regulatory submission requirements. Review and approve labeling and marketing literature. Support Lead Regulatory Affairs Specialist and other Regulatory Affairs staff with all regulatory matters. Work with Lead Regulatory Affairs Specialist and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management. Prepare and / or review written materials for substance and / or policy consistency.

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